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This guidance has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. The ICH Steering Committee has endorsed the final draft and recommended its adoption by the regulatory bodies of the European Union, Japan and USA.

Resources

Name	Format	Description	Link
Guidance Document - Ethnic Factors in the Acceptability of Foreign Clinical Data ICH Topic E5(R1)	HTML		https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/international-conference-harmonisation/efficacy/guidance-document-ethnic-factors-acceptability-foreign-clinical-data-topic.html
Guidance Document - Ethnic Factors in the Acceptability of Foreign Clinical Data ICH Topic E5(R1)	HTML		https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/international-conference-harmonisation/efficacite/facteurs-ethniques-influant-acceptabilite-donnees-cliniques-origine-etrangere-theme.html

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